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阿斯利康旗下的Saphnelo获得欧盟批准用于系统性红斑狼疮

2022-02-17 Allan MedSci原创

阿斯利康本周三宣布,欧盟委员会批准 Saphnelo (anifrolumab) 作为治疗中重度活性自身抗体阳性系统性红斑狼疮 (SLE) 成人患者的附加疗法。

阿斯利康本周三宣布,欧盟委员会批准 Saphnelo (anifrolumab) 作为治疗中重度活性自身抗体阳性系统性红斑狼疮 (SLE) 成人患者的附加疗法。阿斯利康生物制药研发执行副总裁 Mene Pangalos 表示:“Saphnelo 是十多年来在欧洲获得批准的第一个SLE新药”。

系统性红斑狼疮(systemic lupus erythematosus,SLE)是一种系统性自身免疫病,以全身多系统多脏器受累、反复的复发与缓解、体内存在大量自身抗体为主要临床特点,如不及时治疗,会造成受累脏器的不可逆损害,最终导致患者死亡。SLE的病因复杂,与遗传、性激素、环境(如病毒与细菌感染)等多种因素有关。

Saphnelo (anifrolumab) 是一种 I 型干扰素受体抗体,最近在美国、日本和加拿大被批准用于治疗 SLE。欧洲的批准得到了 III 期 TULIP-1 和 -2 研究以及中期 MUSE 试验的支持,这些试验研究了静脉注射Saphnelo (anifrolumab) 治疗中重度 SLE 患者的有效性和安全性。在 TULIP-2 研究中,该药物在多个疗效终点方面均表现出优于安慰剂的优势,但 TULIP-1 未能达到其主要终点。

在 TULIP-2 研究中,共有 362 例患者接受了随机干预:180 例接受 anifrolumab,182 例接受安慰剂。实现缓解的患者百分比在 anifrolumab 组为 47.8%,在安慰剂组为 31.5%(P=0.001)。在具有高干扰素基因特征的患者中,实现缓解的患者百分比在 anifrolumab 组为 48.0%,在安慰剂组为 30.7%;在具有低干扰素基因特征的患者中,该百分比分别为 46.7% 和 35.5%。

阿斯利康目前正在进行 III 期试验以研究 Saphnelo 皮下给药治疗 SLE 的有效性和安全性,同时计划对狼疮肾炎、皮肤红斑狼疮和肌炎进行其他后期试验。

 

原始出处:

https://firstwordpharma.com/story/5500243

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    2022-06-05 zz70
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    2022-02-19 zhouqu_8
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